RecruitingNCT07565727

Cardiometabolic Disease and Substrate Metabolism

Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study

Sponsor

University of Tennessee Graduate School of Medicine

Enrollment

50 participants

Start Date

Dec 10, 2025

Study Type

OBSERVATIONAL

Conditions

Insulin Resistance Pregnancy Pregnancy Complications Preeclampsia Gestational Diabetes Gestational Diabetes Mellitus in Pregnancy Cardiometabolic Diseases Preeclampsia (PE)Gestational Diabetes Mellitus (GDM)Preeclampsia (PE) Risk Gestational Complications Placental Dysfunction

Summary

This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria7

Age 18-45
Any pre-pregnancy BMI
At least one high risk OR one moderate risk factor for pre-eclampsia based on ACOG and USPSTF guidelines
Willingness to adhere to aspirin therapy
Willingness to undergo 2h OGTT for serum collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.
Gestational age at enrollment <18 weeks
Ability to speak, read, and communicate via English

Exclusion Criteria14

Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus
Current gestational diabetes mellitus
Current/active platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura/ITP, thrombotic thrombocytopenic purpura/TTP, von Willebrand disease, etc.)
Thrombophilia
Current use of NSAID for other indication (indomethacin, ibuprofen, etc.)
Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.)
Current or recent use of steroids
Current use of prophylactic or therapeutic anticoagulation
Medical contraindication to aspirin therapy
Molar pregnancy
Renal disease
Inability or unwillingness to give informed consent
Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators